Should the Interoperability of Health Care Records Be the Law of the Land?

Posted on March 10, 2015 I Written By

Andy Oram is an editor at O’Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space.

Andy also writes often for O’Reilly’s Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O’Reilly’s Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

The upcoming three days may be critical to health care in the US. Representative Michael C. Burgess (R-Texas) has introduced a bill to promote the interoperability of health care records, and is accepting comments to his office only through March 13. This bill states valuable goals, but also embodies implications we should be wary of–and some real dangers.

The thrust of the bill is to create a new body called the Charter Organization within the Department of Health and Human Services (but outside the Office of the National Coordinator, which barely earns a mention in the bill). This body, made up of industry stakeholders and members of standards organizations, would define interoperability requirements. Meaningful Use payments would then be contingent on the use of electronic health records that are certified according to the interoperability requirements.

I have covered difficulties with particular issues in the text in another article, so here I’ll focus on the things that worry me the most.

The key element we need to concentrate on is the definition of “authorized users” who have access to records. Burgess’s office is considering whether to allow access only to health care providers, or to permit patients as well. Our response to their question about covering patients must be, “Hell, yes!”

It would be a supreme irony (as well as an outrage) if this bill, which was meant to open up health care records, ended up excluding the people who need access the most–the individuals discussed in those records. Were Burgess to exclude patients from “authorized users,” hospital administrators everywhere would raise a glass of champagne to him and celebrate the eternal slavey of the patient who would never again be able to pry his own information from their grasp.

Next on the list of concerns is the definition of “stakeholders.” In addition to patients, the key stakeholders who are concerned about access to records are clinicians–but the bill offers no assurance that they will be represented on the Charter Organization. Instead, it creates an unwieldy category of “stakeholders” that covers the industries affected by the bill, including “health care providers.”

This provision could easily be satisfied by appointing a couple hospital administrators to the organization. As we know, these people are happy with any “interoperability” that remits insurance payments to their coffers. The interests of doctors, nurses, and other clinicians have never been uppermost in their choice of EHRs.

Finally, let’s hone in on the components of interoperability. The bill says very little about what it would consist of. Clearly, the framers did not want to specify technical solutions, which is commendable. Many health care advocates have advised the government to mandate the behavior of records rather than the technologies that constitute them. Even so, one cannot hope to achieve true interoperability without an understanding of the various levels it encompasses.

  • At the top level, we need agreement on what information is captured. Thus, current standards require fields for various vital signs, test results, etc. If we want to capture something that records have never before concerned themselves with, such as exercise patterns, a standards body has to include that.

  • Standards must then define language for fields and their contents, so that a site receiving a record can find the information it is looking for. CCD-A has done an incomplete job of specifying which field contains which value. A systolic blood pressure should be a systolic blood pressure everywhere, and be easily identified as such. And while everybody agrees on the measures for blood pressure (140 over 100 is bad news no matter who records it), the units for many other measures are not clear, and should be specified in a standard.

  • Finally, the formats and protocols used to exchange data must be standardized. The FHIR standard is the best standard developed so far in health care for data exchange, and meets the current conventions for robust interoperability, known as RESTful APIs. This does not have to be part of the bill, but the bill should mention formats and protocols as part of interoperability.

Although Burgess’s bill raises the right issues, one must look at its context to decide whether it will have a positive or negative impact on health IT. The ONC has already declared interoperability its main goal over the next phase of Meaningful Use. And Meaningful Use is only one leg of the pedestal the ONC is setting up for health IT: standards work and coordination of industry representatives are important parts as well. What does a bill pre-empting the work of the ONC do to all these efforts?

I don’t claim the ONC has always played the strongest role it could have or anticipated all the barriers health reform faces, but Congress has to tread carefully when imposing new requirements and deliberately disrupting the balance that the ONC and CMS have set. Just now, several senators have questioned ONC’s effectiveness. Burgess’s bill does not try to address all the issues, but its impacts will have broad ripple effects.

Whatever you think of the bill, please comment now. Although purportedly focused on the narrow topic of interoperability, its impacts may be felt for years throughout the health care industry.

Update, March 11: to comment on the bill, please write James.paluskiewicz@mail.house.gov.